From: Harrison-Hadler, Lisa (OMHDD) <lisa.harrison-hadler@state.mn.us>
Sent: Monday, June 24, 2024 10:41:28 AM
To: Sarah Price Hancock, MS, CRC <sphancock@psychrecoveryandrehab.com>
Subject: RE: Egregious Ethical Concerns re Mayo Clinic electroconvulsive therapy use

Thank you for contacting the Office of Ombudsman for Mental Health and Developmental Disabilities.  I do want to apologize that my out of office reply referred you to Andrea.  My being out of the office was a planned vacation.  Unfortunately, Andrea had an unplanned emergency that occurred while I was out.  That said, it’s my understanding that you did speak with Wade Oldenburg, Regional Ombudsman for SE MN. 

In addition to what Wade shared with you, I would note that ECT is allowed in Minnesota for clients under civil commitment when certain due process provisions are met – including court review and requiring a court order.  It appears that occurred in this case.  This office does not have the authority to override a court order.  For more information on ECT for involuntary patients subject to civil commitment, you may want to review the Price v. Sheppard MN Supreme Court decision.  Additionally, the commitment statutes, in MN Statute 253B.17, do allow for a person subject to commitment to request court review of any component of the commitment, including ongoing use of ECT.  Mr. Russell should speak with his attorney if he wishes to pursue that option.

Lastly, regarding your concerns about a particular piece of equipment in use at the Mayo Clinic, I would refer you to their Ethics Department.  In the past, I have found them to be a helpful resource, though I don’t have a current contact person to share with you.

Best,

Lisa

Lisa Harrison-Hadler

Ombudsman

Minnesota Office of Ombudsman for Mental Health and Developmental Disabilities

332 Minnesota Street, Ste W1410

First National Bank Building

Saint Paul, Minnesota 55101-2117

O: 651-757-1806

C: 651-529-0014

F: 651-797-1960

Toll Free: 1-800-657-3506

mn.gov/omhdd/

From: Sarah Price Hancock, MS, CRC <sphancock@psychrecoveryandrehab.com>
Sent: Monday, June 17, 2024 3:43 PM
To: Harrison-Hadler, Lisa (OMHDD) <lisa.harrison-hadler@state.mn.us>
Subject: Fw: Egregious Ethical Concerns re Mayo Clinic electroconvulsive therapy use

Dear Ms. Harrison-Hadler, 

By way of introduction, I am a nationally certified Rehabilitation counselor, and former professor of clinical psychiatric rehabilitation at San Diego State University.

As a mandated reporter, it is my duty to raise the issue of suspected abuse in the form of unregulated human experimentation at Mayo Clinic's Electroconvulsive Therapy (ECT) Suite. This situation came to my attention when David Russel, a young man scheduled to receive ECT contacted Mind Freedom in distress regarding his coerced treatment, requesting a "shield". I write on his behalf.

I respectfully suggest the Ombudsman for Mental Health and Developmental Disabilities immediately get up-to-date on the latest FDA and ECT device developments in order to ensure the protection of your state's most vulnerable receiving psychiatric treatment. Please allow me to explain:

In 2018, the FDA’s final ruling on the use of ECT devices, a provisional reclassification of the devices was made, pending ECT device manufacturers’ submission of Premarket Approval Amendments (PMA aka safety studies) and Product Development Protocols (aka dosing consensus standards based on PMA). The FDA ruled that if the device manufacturers do not demonstrate compliance with the special controls, the device will be deemed adulterated under section 501(f)(1)(B) of the FD&C Act and cannot be used on humans without first filing an Investigative device exemption with the FDA (83 FR 66103, 2018).

In 2021, one of the ECT device manufacturers lost product liability insurance and filed for bankruptcy due to the number of pending lawsuits involving permanent, irreversible consequences (Reorg, 2021).

In 2023, Federal court documents in the Thelen v Somatics LLC case (the only other ECT device manufacturer) and personal communication with the FDA revealed no amendments were filed. A jury found Somatics, LLC guilty of "failure to warn" of ECT’s serious adverse events (Wisner Baum, 2023). Risks include "permanent memory loss and permanent brain damage,” among other serious adverse events like non-convulsive status epilepticus, cardiopulmonary arrest, and death (Somatics LLC, 2018, 2021).

Further, court transcripts revealed ECT dosing to generate a therapeutic seizure lasting 30 seconds were “plucked … out of the air” according to well-esteemed psychiatrist and ECT device manufacturer, Dr. Richard Abrams (Wisner Baum, 2023).

In ECT, the electrode is placed directly on or near one of the branches of the trigeminal nerve (Sartorius et al., 2022). This purposefully stimulates the trigeminocardiac reflex (TCR). A standard electrical field dose (0.5 pulse width, 70 Hz, 900mA) pulses 1,120 times in just eight seconds “without any clinical or scientific rationale,”(Abbott et al., 2024; Abbott et al., 2021; Abrams, 2009). The TCR is a clinical phenomenon consisting of sudden onset of hemodynamic perturbations (acute changes in MABP, decreased HR, asystole), respiratory changes (apnea) and gastric changes (hypermotility) resulting from stimulation of any branch of the fifth cranial nerve along its course.”(Meuwly et al., 2015). Consequently, “acute post stimulus bradycardia and asystole are common in ECT”(Sartorius et al., 2022) Purposeful stimulation of the Trigeminocervical Reflex carries a risk so great that it exceeds any benefit—rendering it’s study in humans unethical (Sadr-Eshkevari et al., 2014).

Without PMA Amendments submitted as required to the FDA by the deadline to establish dosing consensus protocols, every time ECT is given at Mayo Clinic (and elsewhere) on a modern ECT device, an electrical field dose is chosen “without clinical or scientific rationale” (Abbott et al., 2024; Abbott et al., 2021).

According to the FDA’s final ruling, without submission of the amendments, no facility can use ECT devices on humans without filing an Investigational Device Exemption (IDE) with the FDA and enrolling the patient in a formal research study associated with the IDE on record with the FDA (83 FR 66103, 2018). 

Without an IDE filed with the FDA, Electroconvulsive Therapy is unregulated, unwitting human experimentation contraindicated by the Mayo Clinic values of Respect, Integrity, Compassion, Healing, Teamwork, Innovation, Excellence, and Stewardship.

The World Health Organization recognizes ECT as an “irreversible intervention.” Giving ECT without free and informed consent “violates the right to physical and mental integrity and may constitute torture and ill-treatment”(World Health Organization & United Nations, 2023)

Please protect patients from torture and ill-treatment by immediately suspending the electroconvulsive therapy of David Russell and any other patient receiving ECT at Mayo without “free and informed consent” who are not registered in a formal trial with the proper investigational device exemption filed with the FDA.

Thank you for your consideration.

Respectfully,

Sarah Price Hancock, MS, CRC

Psychiatric Rehabilitation Consultant

Co-Founder and Trustee, Ionic Injury Foundation

References

Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses, 22 66103-66124 (2018). https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of

Abbott, C. C., Miller, J., Farrar, D., Argyelan, M., Lloyd, M., Squillaci, T., Kimbrell, B., Ryman, S., Jones, T. R., Upston, J., Quinn, D. K., Peterchev, A. V., Erhardt, E., Datta, A., Mcclintock, S. M., & Deng, Z.-D. (2024). Amplitude-determined seizure-threshold, electric field modeling, and electroconvulsive therapy antidepressant and cognitive outcomes. Neuropsychopharmacology, 49(4), 640-648. https://doi.org/10.1038/s41386-023-01780-4

Abbott, C. C., Quinn, D., Miller, J., Ye, E., Iqbal, S., Lloyd, M., Jones, T. R., Upston, J., Deng, Z., Erhardt, E., & McClintock, S. M. (2021). Electroconvulsive Therapy Pulse Amplitude and Clinical Outcomes. Am J Geriatr Psychiatry, 29(2), 166-178. https://doi.org/10.1016/j.jagp.2020.06.008

Abrams, R. S., Conrad M. (2009). Thymatron® System IV Instruction Manual (14 ed.) [Medical Device Instruction Manual]. Somatics, LLC.

Meuwly, C., Golanov, E., Chowdhury, T., Erne, P., & Schaller, B. (2015). Trigeminal cardiac reflex: new thinking model about the definition based on a literature review. Medicine (Baltimore), 94(5), e484. https://doi.org/10.1097/MD.0000000000000484

Reorg. (2021). UPDATE 1: Facing ‘Direct Harassment and Meritless Litigation,’ Electroconvulsive Therapy Device Maker MECTA Corporation Seeks to Reorganize.  https://reorg.com/articles/mecta-corp-first-day-declaration/

Sadr-Eshkevari, P., Schaller, B. J., & Bohluli, B. (2014). Trigeminocardiac reflex: Some thought to the definition. Surg Neurol Int, 5, 43. https://doi.org/10.4103/2152-7806.129617

Sartorius, A., Kellner, C. H., & Sebastian, K. (2022). The Trigeminocardiac Reflex in Electroconvulsive Therapy [LETTERS TO THE EDITOR]. The Journal of ECT, 38(4), 257-258. https://doi.org/10.1097/YCT.0000000000000859

Somatics LLC. (2018). Regulatory Update to Thymatron® System IV Instruction Manual. In.

Somatics LLC. (2021). User Manual: Thymatron System IV (22 ed.) [User Manual]. Somatics LLC, . https://www.thymatron.com/downloads/System_IV_Instruction_Manual_Rev22.pdf

Wisner Baum. (2023, August 16, 2023). Electroshock Therapy (ECT) Trial – Jury finds  Somatics failed to warn of ECT risks.  https://www.wisnerbaum.com/blog/2023/august/electroshock-therapy-ect-trial-jury-finds-somati/

World Health Organization, & United Nations. (2023). Mental health, human rights and legislation: guidance and practice (978-92-4-008073-7). https://www.who.int/publications/i/item/9789240080737

Respectfully, 

Sarah 

Cynics do not contribute. Skeptics do not create. Doubters do not achieve.

Inspire Hope. Share Vision. Motivate Change!